# K223872: Low Profile Companion Sheath

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 19, 2023 after 27 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K924607 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211405: Prelude Guide Sheath, Merit Medical Systems, Inc. (2021) Summary page 4.

## Indications for use
The Merit Low Profile Companion Sheath is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

Source page: https://510kreport.com/device/K223872
Methodology: https://510kreport.com/methodology